跳至主要内容
临床试验/NCT05843214
NCT05843214招募中不适用

Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements in Postoperative Resuscitation Neurosurgery

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 2 个国家目标入组 230 人开始时间: 2023年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
230
试验地点
2
主要终点
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)

研究概览

简要总结

Non-invasive neuromonitoring tools such as transcranial doppler, optic nerve envelope diameter measurement and quantitative pupillometry are routinely used in acute brain injured patients as part of multimodal neuromonitoring with the aim, among others, of detecting episodes of intracranial hypertension, each method allowing the study of one of the different pathophysiological mechanisms of its impact.

However, at present there is no data in the literature on the value of these non-invasive neuromonitoring tools in the management of patients undergoing controlled intracranial surgery.

The study aims to help the early detection of postoperative neurological deterioration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Regulated intracranial surgery: scheduled > 48 hours
  • French-speaking patient
  • No opposition from the patient or a relative when the patient is unable to consent

排除标准

  • Chronic subdural haematoma
  • Isolated cerebral endovascular procedure
  • Stereotactic biopsy
  • Scheduled ventriculoperitoneal shunt or isolated ventriculocisternostomy
  • Specific non-inclusion criteria for quantitative pupillometry: known pupillary abnormalities, glaucoma, cataract surgery and any ocular surgery.

结局指标

主要结局

Evolution of non-invasive neuromonitoring measures (using transcranial doppler)

时间窗: From 1 hour before the surgery until Day 4 post-surgery

This emasure will be performed bilaterally at the level of the first part of the middle cerebral artery, the values collected will be: * Systolic, mean and diastolic velocities; pulsatility index * Estimation of intracranial pressure

Evolution of non-invasive neuromonitoring measures (optic nerve envelope diameter)

时间窗: From 1 hour before the surgery until Day 4 post-surgery

The diameter of the optic nerve envelope will be collected bilaterally using an ultrasound machine

Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)

时间窗: From 1 hour before the surgery until Day 4 post-surgery

The values collected will be : \- Size, quantification of the amplitude of variation to light, latency and speed of constriction of the pupil, presence or absence of anisocoria (defined by a difference \>1mm in size between the two pupils)

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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